NCT01415024

Resynchronization in Paced Heart Failure Patients With Implantable Cardioverter Defibrillator (ICD) Indication

Resynchronization in Paced Heart Failure Patients With ICD Indication

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Schuechtermann-Klinik · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Today patients with a Cardiac Resynchronization Therapy (CRT) indication usually receive 2 ventricular leads, right ventricular (RV) apex and left ventricular (LV) (postero-) lateral, gaining a responder rate of approximately 70%. However, the physiological agitation of the left ventricle takes place over two pathways. Therefore single point stimulation might be insufficient for a dilated, insufficiently and asynchronously contracting left ventricle, resulting in either insufficient or no response to the therapy. In the "CRT ICD Dual LV" study the patients receive a second LV lead in an anterior vein. When this lead is placed, temporary dual LV stimulation is started. To assess the effectivity of the dual LV lead stimulation intraoperatively a LV dp/dt-pressure measurement is taken. If there is an increase in LV dp/dt, the patients will be stimulated with both leads permanently. If not they will be stimulated conventionally. The patients participating in this study are monitored for 12 months after implantation.

Conditions

• Heart Failure
• Left Bundle-Branch Block

Interventions

Type	Name	Description
PROCEDURE	second LV lead in CRT	second LV lead in CRT

Timeline

• Start date: 2011-05-01
• Primary completion: 2012-05-01
• First posted: 2011-08-11
• Last updated: 2011-08-11

Locations

1 site across 1 country: Germany